Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT00258258
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of relapsed or refractory multiple myeloma (MM) or other plasma cell disorder (PCD)
* At least one previous treatment for MM or PCD required
PATIENT CHARACTERISTICS:
Performance status
* ECOG 0-2 OR
* Karnofsky 60-100%
Life expectancy
* At least 3 months
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Calcium ≤ 10.5 mg/dL
* No renal stone formation within the past 5 years for patients who have had curative therapy for a condition associated with the risk of stones (e.g., hyperparathyroidism, bladder dysfunction, obstructive uropathy) OR had a single episode of confirmed urolithiasis
* No calculi in urinary tract confirmed by renal ultrasonography, kidney, ureter, and bladder (KUB) x-ray, or other imaging modality
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No uncontrolled cardiac arrhythmia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during study and for 3 months after study completion
* No osteonecrosis of the jaw
* No history of allergic reaction attributed to compounds of similar chemical or biological composition of calcitriol, paricalcitol, or zoledronate
* No uncontrolled intercurrent illness that would preclude study compliance
* No ongoing or active infection
* No psychiatric illness or social situation that may preclude study compliance
PRIOR CONCURRENT THERAPY:
Chemotherapy
* More than 4 weeks since prior chemotherapy
Endocrine
* More than 4 weeks since prior high-dose steroids
Other
* No other concurrent investigational agents or therapies for multiple myeloma or plasma cell disorders
* No concurrent digoxin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00258258
Study Brief:
Protocol Section:
NCT00258258